Sleep Self-management in Pregnancy Using a Personalized Health Monitoring Device

Pregnancy-associated sleep disorders are a common acute experience in pregnancy experienced by up to 82% of women. Sleep disorders are associated with increased risk for pre-eclampsia, gestational diabetes, longer labor, cesarean birth, and postpartum depression, and are higher among pregnant women of lower socioeconomic status. Traditional clinical management of sleep disorders in pregnancy includes education and counseling on sleep hygiene and sleep positioning, dietary modifications, relaxation, iron supplementation, weight management, and physical activity, yet education-based behavioral interventions show minimal effectiveness for improving sleep among pregnant women. These methods typically do not incorporate objective self-monitoring, which is an important behavior change technique. In pregnancy, objective self-monitoring on a day-to-day basis is particularly important as sleep disorders may worsen as pregnancy progresses.

Computer-based personalized health monitoring (PHM) devices may serve as an effective tool with which pregnant women can self-manage sleep through incorporation of regular feedback. This strategy may be beneficial not only for women with pregnancy-associated sleep disorders but also for pregnant women with less severe sleep disruptions that experience daytime sleepiness, fatigue, and decreased quality of life. PHM devices have been used to promote weight loss, diet, and physical activity changes but no studies have specifically targeted sleep among pregnant women. The purpose of this pilot study is to establish the feasibility and acceptability of conducting a 12-week intervention for sleep self-management with pregnant women using a PHM device, in order to refine the intervention for a larger, randomized trial.

Study Overview

• Status: Completed
• Conditions: Sleep; Pregnancy
• Intervention / Treatment: Behavioral: Misfit Shine 2

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Amherst, Massachusetts, United States, 01003
      • University of Massachusetts Amherst

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria: at time of recruitment (t0) women must:

1. be age ≥ 18
2. 14 to <24 completed weeks gestation of pregnancy

2) have no known maternal or fetal complications 3) have a smartphone compatible with the study PHM device 4) have internet access 5) be English speaking 6) be receiving prenatal care.

Exclusion Criteria:

1. pre-existing diabetes mellitus or hypertension
2. diagnosed sleep disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep education plus Misfit Shine 2; This arm receives sleep education from the study nurse and also receives a Misfit Shine 2 to wear for 12 weeks to self-monitor sleep.	Behavioral: Misfit Shine 2; The intervention group was given a Misfit Shine 2 to monitor sleep throughout the 12-week intervention period. Participants were instructed to wear the device on the wrist, which is better for capturing sleep than the other wear locations. Participants were instructed on how to self-monitor total sleep time and select a goal for that behavior. Further, participants were asked to view feedback on their sleep time daily on the Misfit smartphone app, which they used to monitor their progress toward achieving their behavioral goals.
No Intervention: sleep education only; This arm receives only sleep education from the study nurse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants that remain in the study for the entire study period for the intervention and control groups.	To assess feasibility of the study, we will calculate the number and percentage of participants in both groups that remain in the study for the entire study period. The study will be considered as feasible if at least 80% of participants remain in the study for its entirety.	24 to 36 weeks gestation of pregnancy
Percentage of days during which the Misfit Shine 2 is worn by participants in the intervention group.	To assess feasibility of the study, for women in the intervention group, we will calculate the proportion of the number of days the Misfit Shine 2 is worn during the study period. We will consider the intervention as feasible if participants wear the Misfit Shine 2 at least 80% of days during the study period.	24 to 36 weeks gestation of pregnancy
Participant satisfaction with the sleep education (both groups) and with the Misfit Shine 2 (intervention group only) will be assessed through qualitative interviews.	At 36 weeks gestation, all participants will be asked to take part in a semi-structured qualitative interview in which open-ended questions will be asked about their sleep patterns, barriers and facilitators of sleep, and whether the sleep education was deemed helpful. Intervention group participants will additionally be asked questions about the experience wearing the MisFit Shine 2, their like and dislikes, and whether they believe it would be helpful to other pregnant women.	36 weeks gestation of pregnancy.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality and duration as measured by the Pittsburgh Sleep Quality Index (PSQI)	The PSQI is a 19-item survey questionnaire measuring perceived sleep quality and disturbance over the past month. It has been used in numerous studies with pregnant women and has been validated for pregnant women using confirmatory factor analysis and has reliability of .7460. Scores ≥ 5 will be considered indicative of poor sleep.	24 to 36 weeks gestation of pregnancy
Sleep disturbances as measured by the PROMIS SF v1.0-Sleep Distrubance 6a	The PROMIS SF v1.0-Sleep Distrubance 6a is a validated 6-item survey questionnaire that measures individual perceptions of sleep quality and disturbance in the past seven days using a 5-point Likert scale. It is scored by summing responses for all items (two are reverse scored); higher scores indicate higher sleep disturbance.	24 to 36 weeks gestation of pregnancy
Excessive daytime sleepiness as measured by the Epworth Sleepiness Scale	The Epworth Sleepiness Scale is an 8-item survey questionnaire of daytime sleepiness. It has been validated for measuring symptoms of daytime sleepiness in pregnant women using principal components and confirmatory factor analysis, and has a reliability coefficient of 0.75. Higher cumulative scores indicate higher sleepiness.	24 to 36 weeks gestation of pregnancy
Fatigue as measured by the PROMIS Fatigue Short Form 4a	This 4-item survey questionnaire measures fatigue in the past seven days with a 5-point Likert scale. Responses for all items are summed; higher scores indicate higher fatigue symptoms.	24 to 36 weeks gestation of pregnancy
Depressive symptoms as measured by the PROMIS Depression Short Form 6a and the Edinburgh Postnatal Depression Scale	The PROMIS Depression Short Form 6a is a 6-item survey questionnaire that measures depressive symptoms in the past seven days using a 5-point Likert scale. It is scored by summing the responses for all items; higher scores indicate higher depressive symptoms. It has been validated for use with several chronic illnesses. The PROMIS Depression Shoft Forma 6a is a common data element measurement tool that is supported by the NIH but it has not be validated with pregnant women. Therefore, we will additionally measure depressive symptoms using the Edinburgh Postnatal Depression Scale. The Edinburgh Postnatal Depression Scale is a 10-item survey questionnaire designed to detect depressive symptoms in postpartum women, with support detection of depressive symptoms in pregnancy. Scores range from 0 to 30; higher scores indicate higher depressive symptoms. We will use scores > 12 to indicate depression.	24 to 36 weeks gestation of pregnancy

Collaborators and Investigators

• Sponsor: University of Massachusetts, Amherst
• Collaborators: University of Pittsburgh

Publications and helpful links

General Publications

• Hawkins M, Iradukunda F, Paterno M. Feasibility of a Sleep Self-Management Intervention in Pregnancy Using a Personalized Health Monitoring Device: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2019 May 29;8(5):e12455. doi: 10.2196/12455.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): July 18, 2018
• Study Completion (Actual): August 27, 2018

Study Registration Dates

• First Submitted: December 17, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 21, 2018

Study Record Updates

• Last Update Posted (Actual): December 21, 2018
• Last Update Submitted That Met QC Criteria: December 18, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2017-3846

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No